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Pre-Surgery Radiation Therapy for Mesothelioma (SMARTER Trial)

N/A

Waitlist Available

Led By John Cho, MD, PhD

Research Sponsored by University Health Network, Toronto

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Good pulmonary function precluding radiation therapy (FEV1>1 L or >40% predicted or DLCO >45% predicted)

Eastern Cooperative Oncology Group (ECOG) performance status of 0-2

Must not have

Previous thoracic irradiation.

Poor performance status ECOG 3-4.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to five years

Awards & highlights

No Placebo-Only Group

Summary

This trial will test different doses of radiation to find the maximum amount a patient can tolerate while still being effective in treating their cancer.

Who is the study for?

Adults over 18 with early-stage malignant pleural mesothelioma, good lung function, and performance status. They must be new diagnoses without prior thoracic radiation or chemotherapy for this cancer or others within the last 3 years (except certain non-invasive cancers). Pregnant women are excluded.

What is being tested?

The study is testing how much radiation can be safely given to mesothelioma patients before surgery. It involves increasing doses of background plus boost radiation until reaching a maximum safe level or a set dose limit.

What are the potential side effects?

Potential side effects may include skin reactions, fatigue, inflammation of lung tissue leading to coughing and difficulty breathing, as well as other risks typically associated with high-dose radiation therapy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My lung function is good enough that I can't have radiation therapy.

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I can take care of myself and am up and about more than half of my waking hours.

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I am 18 years old or older.

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My cancer is in an early to mid-stage and has not spread far.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had radiation therapy to the chest area before.

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I need help with my daily activities or am unable to do them.

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My lung function is too low for radiation therapy.

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I am under 18 years old.

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My cancer has spread to the lymph nodes on the opposite side of my chest.

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My cancer has spread to distant parts of my body.

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I do not have serious illnesses like heart or lung disease that would prevent me from receiving radiation treatment.

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I am not currently pregnant or breastfeeding.

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I have had chemotherapy for cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to five years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to five years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to five years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Maximum Tolerated Dose for Background Radiation

Secondary study objectives

Evaluating patients' pain

Local recurrence

Patient Morbidity

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: RadiationExperimental Treatment1 Intervention

This study involves a 3+3 design. The starting cohort (n=3) will receive a neoadjuvant Background dose to the affected hemithorax (starting at 0 cGy) as well as concomitant Boost dose (of at least 2100 cGy) to a part of the gross tumour volume (GTV). The radiation will be delivered over 3 alternate days over 5-7 calendar days followed by macroscopically complete extensive pleural resection (either extra-pleural pneumonectomy or extended pleurectomy decortication, at the surgeon's discretion) after 7 to 14 days. If no dose limiting toxicities (DLTs) seen, then the Background RT dose will be increased by 600 cGy (up to 1800 cGy) and the cohort (n=3) for the next dose level will be accrued. If only 1 DLT seen, then an additional 3 patients will be treated on this dose level. If 2 or more DLTs seen at any given dose level, then the previous dose level will be defined as the maximum tolerated dose (MTD). Patients will be stratified by type of resection.

0 / 13Eligibility criteria met